Pilot double blind study to assess the efficacy and tolerability of morphine sulphate oral solution (Oramorph) given as add-on therapy in the preventive analgesia (pre-medication) in patients undergoing laparascopy cholecistectomy - PREVENT

MOLTENI0 个研究点开始时间: 2010年12月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Written informed consent obtained,
•2.Patients of either sex aged >=18 and = 65 years;
•3.Patients candidate to surgical intervention of laparascopy cholecistectomy;
•4.Patients in class I, II or III physical status of the classification system of American Society of Anesthesiologists (ASA);
•5.Absence or mild pre-operative pain (i.e. a NRS score between 0-3 included);
•6.Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner). A negative pregnancy test on blood must be obtained at the screening visit, if applicable;
•7.Patient’s co-operative attitude and able to understand and adhere to study protocol procedures and timelines
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Patients in class IV-VI of the ASA;
•2.Any use of opioid analgesic drugs;
•3.Use of opioids or other analgesic drugs in the 12 hours preceding the programmed surgical intervention;
•4.Patients with renal (serum creatinine = 1.4 mg/dL), or hepatic failure, or diabetes mellitus which represent a risk to the subjects;
•5.Severe cognitive impairment, or mental deterioration, or major psychiatric diseases, as confirmed by a baseline Mini-mental state examination (MMSE) score < 24;
•6.Known or suspected intolerance, or contraindications in the use of study medications and/or study medications’ formulation ingredients;
•7.History of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements;
•8.Breastfeeding females;
•9.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
•10.Patients who received any investigational drug within the last 12 weeks;
•11.Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.

发起方

MOLTENI